The purpose of this study was to compare the rate of surgical site infections in patients randomized to Irrisept versus SoC, who had an open abdominal laparotomy for abdominal trauma or acute surgical abdomen.
The trial was explained to potential subjects, the informed consent was completed and and eligibility was verified. After this, the subjects were randomized to Irrisept or SoC and an open abdominal laparotomy with primary closure due to (1) blunt or penetrating abdominal trauma or (2) acute surgical abdomen was performed. The follow-up visit was performed approximately 30 days later.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
627
The IrriSept system consists of two containers: Step1, a sterile bottle of 450 mL 0.05% Chlorhexidine Gluconate in 99.95% water and Step 2, a sterile bottle of 450 mL of sterile 0.9% Normal Saline. Step 1 and Step 2 are identical in shape and size, with a clear distinction in labeling between. Their unique design allows the solutions to be delivered under the ideal pressure as determined by the surgeon via manual compression for wound and surgical irrigation. Subjects randomized to the IrriSept system will receive irrigation per the provided Instructions for use; those randomized to Standard of Care will receive routine care per discretion of the investigator and in accordance with the institution's guidelines, which may or may not include some other type of irrigation.
Institution will provide routine Standard of Care (SoC) as surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
The University of Arizona
Tucson, Arizona, United States
The University of Southern California, USC Medical Center
Los Angeles, California, United States
Percent of Subjects With Surgical Site Infections (SSI)
The primary endpoint was the rate of SSIs observed 30 days from the date of the index operation.
Time frame: 30 (+/- 3) days post-surgical procedure
Hospital Readmission Rates
A secondary endpoint was the rate of Irrisept versus SoC subjects that required hospital readmission due to SSIs.
Time frame: 30 (+/- 3) days post-surgical procedure
Hospital Costs
A secondary endpoint was the estimated hospital cost to charge ratio between Irrisept and SoC subjects. No data was collected towards this objective; thus, the success or failure of this endpoint was not assessed.
Time frame: 0 days
Length of Hospital Stay
A secondary endpoint was the length of hospital stay between subjects randomized to Irrisept versus SoC.
Time frame: 30 (+/- 3) days post-surgical procedure
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Denver Health and Hospital Authority
Denver, Colorado, United States
The University of South Florida, Tampa General Hospital
Tampa, Florida, United States
The University of Iowa
Iowa City, Iowa, United States
The University of Kentucky Research Foundation
Lexington, Kentucky, United States
The University of Maryland, Baltimore
Baltimore, Maryland, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Saint Louis University
St Louis, Missouri, United States
The University of Cincinnati Health
Cincinnati, Ohio, United States
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